Cleared Traditional

AEON Endoscopic Stapler (K201882) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201882 · Lexington Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
93d
Days
Class 2
Risk

K201882 is an FDA 510(k) clearance for the AEON Endoscopic Stapler. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Lexington Medical, Inc. (Billerica, US). The FDA issued a Cleared decision on October 9, 2020 after a review of 93 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4750 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Lexington Medical, Inc. devices

Submission Details

510(k) Number K201882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2020
Decision Date October 09, 2020
Days to Decision 93 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 115d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GDW Staple, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GDW Staple, Implantable

All 128
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K201882.
GIA Stapler with Tri-Staple Technology
K202701 · Covidien · Dec 2020
Tri-Staple 2.0 Reloads
K202864 · Covidien · Oct 2020
Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm
K202665 · Ethicon Endo-Surgery, LLC · Oct 2020
Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed
K201280 · Ethicon Endo-Surgery, LLC · Jul 2020
Signia Stapler (with new software)
K201672 · Covidien · Jul 2020
Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green
K200420 · Ethicon Endo-Surgery, LLC · Jun 2020